drugset / Trial / NCT04587778

Imaging Neural Correlates of Ketamine Using PET/MR

NCT04587778

Phase 1 Unknown 65 enrolled Medical University of Vienna
RandomizedCrossoverDouble-blindBasic science

Summary

The purpose of this randomized, placebo-controlled study is to investigate pharmacodynamic differences between racemic ketamine and esketamine using functional fluorodeoxyglucose (\[18F\]FDG) positron emission tomography/magnetic resonance imaging (PET/MR) Pilot study I: A pilot study with healthy controls will be performed in order to investigate pharmacokinetic behavior and acute behavioral effects of intravenous ketamine infusion. Pilot study II: A pilot study including 15 healthy volunteers will be performed in order to optimize scanning procedures. The pilot study follows a randomized, placebo-controlled, double-blind, cross-over study design. After enrollment into the study all subjects will undergo two \[18F\]FDG PET/CT scans in the course of which they will receive either S-ketamine or placebo during the first scan and the respective other study medication during the second scan.

Timeline

Start
2020-10-05
Primary completion
2025-03-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified Intravenous
Subject Ketamine Small molecule Intravenous